PROMISE study to investigate neurostimulation for failed back surgery syndrome launched by Medtronic

4th February 2013

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A company release on the 28 January from Medtronic announced the start of PROMISE (Prospective, randomised study of multicolumn implantable lead stimulation for predominant low back pain). This is the first-ever, large-scale study comparing the effectiveness of Medtronic neurostimulation therapy with Specify 5-6-5 multicolumn surgical leads plus optimal medical management to the administration of optimal surgery syndrome alone in patients with failed back surgery syndrome and predominant low back pain.

“Chronic pain is a clinically challenging and often debilitating condition for which oral medications may provide insufficient relief,” said Bart Edmiston, principal investigator for the PROMISE study at The Neuroscience Center, Ocean Springs, Mississippi, USA, which enrolled the study’s first patient on 8 January 2013. “The PROMISE study will add to the growing body of evidence supporting Medtronic neurostimulation therapy, a well-established therapeutic approach, for the patients worldwide who continue to experience low back pain following back surgery.”

It is estimated that more than 100 million US adults and one in five European adults live with chronic pain. Back pain is the most prevalent type of chronic pain, affecting approximately 10% of the US population alone. Failed back surgery syndrome is defined as persistent or recurring pain in the back or legs following one or more spine surgeries. The majority of failed back surgery syndrome patients receive physical rehabilitation and/or oral medications to help manage their pain, but studies and clinical experience find that many of these patients will not sufficiently improve and will require additional interventions.

Medtronic neurostimulation therapy (also known as spinal cord stimulation) is a widely established treatment option for chronic back and/or leg pain that has been used to treat more than 250,000 people worldwide. It uses a medical device to deliver mild electrical impulses to the spinal cord to block pain signals from reaching the brain.

PROMISE is a prospective, randomised, open-label, parallel-group, clinical study enroling up to 300 individuals suffering from predominant chronic low back pain due to failed back surgery syndrome at 30 centres in the USA , Canada and Europe (Belgium, France, Germany, Spain, The Netherlands and UK). It is the first large-scale, randomised, controlled clinical trial designed to assess the value of spinal cord stimulation for predominant low back pain with leg pain using a surgical lead, in contrast to previous studies of this technology, which have focused on predominant leg pain.

“Spinal cord stimulation has become an increasingly valued treatment approach in chronic pain, and we look forward to participating in the latest study,” said Philippe Rigoard, the study’s global principal investigator, who started enrolling patients 14 January at Poitiers University Hospital, Poitiers, France. “If the PROMISE results are positive, they will provide critically needed relief for those patients suffering from chronic low back pain associated with failed back surgery syndrome.”

PROMISE participants will be randomised 1:1 to receive treatment with either spinal cord stimulation with optimal medical management or optimal medical management only. After a six-month observational phase, the study will compare the proportion of participants in the spinal cord stimulation group who report more than 50% reduction in low back-pain intensity, as measured by the Numeric Pain Rating Scale, with those in the optimal medical management-only group. Health care utilisation data collected will be used to develop cost analysis models for potential use in future studies evaluating the long-term economic impact of spinal cord stimulation.

“Medtronic is committed to advancing the understanding of its neurostimulation therapy in patients with low back pain resulting from failed back surgery syndrome,” said Julie Foster, general manager and vice president, Pain Stimulation and Targeted Drug Delivery in the Neuromodulation business of Medtronic. “PROMISE provides the opportunity to assess not only the degree of pain relief provided by spinal cord stimulation plus optimal medical management compared to optimal medical management alone in failed back surgery patients, but also to evaluate the economic and quality of life impact of this treatment by looking at such important measures as sleep, ability to work and changes in pain medication.”